Antimicrobial Product Efficacy Tests for FDA & Global Submissions
Global expertise, personal touch
Demonstrating antimicrobial effectiveness is a core regulatory requirement for a wide range of topical healthcare products — including healthcare personnel hand washes, surgical scrubs, antiseptic patient skin preparations, and hand sanitizers.
Antimicrobial Product Efficacy Tests generate the high-quality data required to support antimicrobial claims and regulatory submissions with agencies such as the U.S. Food and Drug Administration (FDA), Health Canada, and the European Commission.
Eurofins CRL operates a dedicated, Good Clinical Practice (GCP)-compliant facility in Texas that focuses exclusively on the topical antimicrobial market. Our laboratory conducts rigorous in vivo efficacy studies that meet the demands of high-stakes regulatory pathways, including New Drug Applications (NDAs). With expertise across U.S. and international standards, we offer a single-source solution for brands seeking global market access.
Our Suite of Topical Antimicrobial Testing Standards
We offer a comprehensive portfolio of testing services based on globally recognised ASTM and EN standards. These capabilities are designed to meet the specific efficacy validation needs of rinse-off soaps, leave-on Sanitizers, and high-performance surgical scrubs.
Healthcare Personnel Hand Wash (ASTM E1174, EN 1499)
These standards evaluate rinse-off antiseptic soaps and washes used in healthcare and food service environments. Testing to both North American (ASTM) and European (EN) protocols ensures global readiness.
View Hand Wash Testing Details
Hygienic Hand Rub & Sanitizers (EN 1500, ASTM E2755)
We provide efficacy testing for alcohol-based and other leave-on hand rub formulations according to the key standards required for market access in the U.S. and Europe.
Surgical Scrub Evaluation (ASTM E1115)
The ASTM E1115 standard represents one of the most rigorous assessments of antimicrobial efficacy. It evaluates surgical scrub formulations for both immediate and sustained microbial reduction — essential in critical care environments.
View Surgical Scrub Evaluation Details
Specialised & Screening Methods (Finger Pad, CHG Compatibility)
Beyond compendial methods, we offer specialised studies including finger pad screening, persistent efficacy testing, and CHG (chlorhexidine gluconate) compatibility evaluations — all tailored to healthcare-specific product requirements.
FAQs
Q1: What is antimicrobial product efficacy testing?
It measures how effectively a topical product reduces or eliminates harmful microorganisms under controlled conditions.
Q2: Which standards are followed for topical antimicrobial testing?
Testing follows ASTM, EN, and FDA-recognized protocols to ensure global regulatory acceptance.
Q3: What types of products require antimicrobial efficacy testing?
Products such as hand Sanitizers, healthcare personnel hand washes, surgical scrubs, and antiseptic skin preparations require antimicrobial efficacy validation.
Q4: Does Eurofins CRL provide global regulatory support?
Yes, our testing data support submissions to the FDA, Health Canada, and the European Commission for worldwide product approval.
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